Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Silence]

Phi: I know this. But this does not change the fact that an indefinite-term nicotine replacement product is what the ecig is.

Sry I have something to say here... Thank you Sun for all the updates. I have been silent (no pun intended) but I believe that a term needs to be addressed. NRT (Nicotine Replacement Therapy) implies that you are trying to replace your nicotine consumption. As far as I am aware, ALL NRT products are designed to do exactly that, replace nicotine. They eventually strive for no nicotine. I am not trying to replace my nicotine. You wouldn't like me without nicotine (may not anyway). I am simply finding a better way to get the nicotine that I want and choose to have. So I feel a better term for an ecig would be a TRP (Tobacco Replacement Product). as far as indefinite use... I completely agree there. I have no plans to ever stop vaping. As far as the court case is concerned... If the FDA seeks to ban, instead of regulating, ecigs/e-liquid it will lead people, with enough know how and not enough knowledge of the dangers, to attempt to make their own nicotine and e-liquid. Then we will see some deaths. I would rather have a stable, controlled, consistent, product than none at all. Companies should conform to ISO standards and as we are consuming this product, I personally would like to know that it isn't made in some guys basement while he is having a beer or 6. Conformation of some of these processes, I believe, is essential. one definition of drug is "a substance other than food intended to affect the structure or function of the body" ( drug - Definition from the Merriam-Webster Online Dictionary ). Nicotine definatly falls into this catagory. I personally believe that the FDA has conduted themselves inappropriately, in regards to the seizing of these products. A fairly quick toxicology report would have shown them not to be a threat, to the body or national security, and should have been released without question. But I feel that some good can come of this. This may help foster competition. That would hopefully mean better product at lower prices. All I can really say is that I am on MY side. I care about what I think is best for ME. Smoking is definately not it. I will continue to vape regardless.

[Cori]

On the lighter side and some borrowed lyrics from Bob Dylan... Many thanks to Legal One and Sun Vaporer for all the updates and insight, much appreciated.

Hey! Mr. FDA Man, don't take my vape away from me,
I'm not sleepy and there is no place I'm going to.
Hey! Mr. FDA Man, don't take my vape away from me,
In the jingle jangle morning Judge Leon will be followin' you.

Though I know Judge Leon's rule might pluck my head out from the sand,
Don't let my ecig be, Vanished from my hand,
Don't leave us blindly here, awake from fear of sleeping
My weariness amazes me, Waiting for Judge Leon to defeat
Mr. FDA man, let us not meet
You're the ancient enemy too dead for dreaming

Hey! Mr. FDA Man, don't take my vape away from me,
I'm not sleepy and there is no place I'm going to.
Hey! Mr. FDA Man, don't take my vape away from me,
In the jingle jangle morning Judge Leon will be followin' you.

Please don't let this song get stuck inside your busy head
Where Legal One and Sun Vaporer never need fear to tread
Hey! Mr. FDA Man, don't take my ecig away from me
In the jingle jangle morning Judge Leon will be followin' you.

[Vocalek]

I know this. But this does not change the fact that an indefinite-term nicotine replacement product is what the ecig is. One of the current battlefronts at hand is to seek to have such a class of products be created.

Knowing that the FDA already has a mind-set that "nicotine replacement" = "nicotine weaning" we would be better off to come up with a different description. Do you consider yourself to be receiving treatment when you use your PV? (You do use one, don't you?) I think "smoking replacement product" is a more accurate description. Maybe there is one that is better, but I don't think we have a snowball's chance in H-E-double-hockysticks of getting this product, containing dosages that are the most effective for us, approved as a "nicotine replacement" product by FDA.

Let me ask you this. If it were your millions, would you have filled out the NDA paperwork proposing the Ruyan Electronic Cigarette be considered for approval as a "nicotine replacement product"? I sure wouldn't.

Vocal: They (Ruyan) are not a pharmaceutical / medical device company.

Phi: Actually, they are.

Actually, I think that calling Ruyan Holdings Inc. themselves a pharmaceutical company is a bit of hyperbole on the part of the holding company's PR department. They manufactured ginseng products. Recently they have begun manufacturing a generic version of Norvasc. The other two drugs mentioned on the Holding Company's Web site appear to be herbal formulations. Do you know of any drug that they have put through the FDA's New Drug Application process?

Phi: I've heard that Ruyan does intend to conduct these tests; and is cheerleading the FDA's actions.

I saw the press release about applauding the FDA. Still doesn't mean that Ruyan has either the capitol or the expertise to go through the NDA process.

Vocal: I don't consider this a "drug product."

Phi: But the law does.

That remains to be seen. The judge hasn't ruled yet. But if "intended use" is the pivotal point , and the intended use is to be an alternative to smoking tobacco, then it isn't a drug product. The intended use is not to treat a disease.

Phi: We should also want to know that inhaling vaporized pg or glycerin in a chronic long-term manner does not itself introduce new dangers.

Phil, I don't know how long you smoked. I smoked for 45 years, and I can testify to the fact that inhaling tar and other nasties in a chronic-long term manner causes wheezing, phlegm, and coughing. When I stopped inhaling that stuff and began inhaling PG, flavoring, and nicotine, the wheezing went away, as did the phlegm and coughing. Now maybe 20 years down the road we will find out that long-term inhaling of PG is harmful in some way. By then, the smoking would have killed me anyway.

So, no I am not concerned about it. Curious, sure, but not worried. My body is telling me that I am worlds healthier after 8 months on PG than I used to be.

[BardicDruid]

What really gets me is e-cigs where banned because of a trace amount of Diethylene glycol. Well my uncle was in the tobacco business for a number of years and I remember when the CigCorp's wanted to use this new stuff on the cured tobacco. My uncle went nuts, it was really expensive, this new stuff was Diethylene glycol.

It's used after the curing process when the tobacco is dry, it gives it some moisture so when a flame is added it doesn't burn like paper. That's the main reason modern cigars and pipe tobacco will go out in not puffed on regularly. *It's called a humectant so they don't have to use the real name.

So how much of the DEG do you get when smoking analogs???? No one will even try to answer that one, the government and CigCorp's wanna keep that little tid-bit as quite as possible.

I thought I would post this for some food for thought.

[PhiHalcyon]

Vocalek,

Yes, I do use an ecig/PV; and have for about the same amount of time that you have. I was a three pack a day smoker, and had smoked for about 27 years. And at 6'2", 275lbs., and 43 years old, it had clearly taken its toll on me. So, when my doctor told me that if I really loved my daughter, then I would quit; well, that's when I began researching my options, and stumbled upon the ecig.

So, yes, I agree that the ecig is as much a smoking replacement as it is a nicotine replacement product, but the current regulatory scheme leaves only the drug product classification available for it. And this really has nothing to do with intended use, but with the fact that selling nicotinated non-tobacco products is prohibited under the new Tobacco Control Act.

Rather than try to redefine the ecig into a legal category that does not exist, I believe it to be wiser to conform the ecig to the tobacco product classification. This is what I am personally working on; and it has the added benefit of delivering the full spectrum of tobacco alkaloids, rather than just nicotine.

We can let the ecig go to the drug product dungeon without losing the benefits that it has brought us. It's just going to take a little bit of time.

[kinabaloo]

Well done to Vocalek and Tvujek for some sanity here.

This is not some arcane debate; it is an extremely serious one. Only a pragmatic approach can really achieve a reduction in deaths from smoking. And that means allowing effective, long-term alternatives; the danger of nicotine is negligible compared to all the combustion products.

[oldlady]

Finally, the definitive study we have all been waiting for! I had a lingering suspicion my hat was not working properly, but I thought it was the microwave...

On a more serious note, PhiHalcyon raises a good point. I just hope the courts and the FDA can find a way to resolve this issue - i.e., certification, testing, and industry standards - without taking e-cigarettes off the market. If I were allowed to take a decision on this, I would go on the basis of the NIH findings, the reports by the American Association of Physicians, and Michael Siegel's conclusions and give manufacturers a grace period in which to do whatever they were supposed to do in the first place to make the FDA happy.

Yes, I know the NIH does not apply in the United States, but what the heck. Several other countries have put in place bans based on the much flimsier FDA report!

[Slickstick]

The main reason people smoke cigarettes in the first place is for the nicotine. I don't see how e-cigs can ever be illegal as long as cigarettes are legal. From the data sheet I saw somewhere on here, I believe it was from TW, not sure, it listed all the ingredients found in a lab report. And that was a nicotine/pg made report anyway. I'm sure vg would be even cleaner. Compare that to any cigarette report and see what you come up with.

[Silence]

Just a question... Can you get nicotine from ANYTHING other than tobacco? we know you can get milk from goats, coconuts, cows, soy...etc.

[oldlady]

Yes, as I understand it, nicotine is found naturally in tomatoes, potatoes and other foods.